Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sonidegib
Drug ID BADD_D02472
Description Sonidegib is a Hedgehog signaling pathway inhibitor (via smoothened antagonism) developed as an anticancer agent by Novartis. It was FDA approved in 2015 for the treatment of basal cell carcinoma.
Indications and Usage Sonidegib is approved for use in the US and EU for treatment of adults with locally advanced basal cell carcinoma (BCC) that has recurred post surgery or radiation therapy. It is also approved for adult patients with BCC who are not eligible for surgery or radiation therapy. (2)
Marketing Status Not Available
ATC Code L01XJ02
DrugBank ID DB09143
KEGG ID D10119
MeSH ID C561435
PubChem ID 24775005
TTD Drug ID D09BNZ
NDC Product Code 47335-303
Synonyms sonidegib | (1,1'-Biphenyl)-3-carboxamide, N-(6-((2R,6S)-2,6-dimethyl-4-morpholinyl)-3-pyridinyl)-2- methyl-4'-(trifluoromethoxy)-, rel- | Odomzo | N-(6-((2S,6R)-2,6-dimethylmorpholino)pyridin-3-yl)-2-methyl-4'-(trifluoromethoxy)biphenyl-3-carboxamide | LDE225 | NVP-LDE225
Chemical Information
Molecular Formula C26H26F3N3O3
CAS Registry Number 956697-53-3
SMILES CC1CN(CC(O1)C)C2=NC=C(C=C2)NC(=O)C3=CC=CC(=C3C)C4=CC=C(C=C4)OC(F)(F)F
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.0010.000533%Not Available
Alopecia23.02.02.0010.000799%
Amenorrhoea21.01.02.001; 05.05.01.0020.000533%
Anxiety19.06.02.0020.000533%
Arthralgia15.01.02.0010.000533%
Atrial fibrillation02.03.03.0020.000799%
Basal cell carcinoma23.08.02.001; 16.03.02.0010.000799%Not Available
Chills15.05.03.016; 08.01.09.0010.000533%
Death08.04.01.0010.000417%
Dehydration14.05.05.0010.000533%
Diarrhoea07.02.01.0010.001066%
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.0040.000799%
Dysgeusia17.02.07.003; 07.14.03.0010.000533%
Dyspnoea22.02.01.004; 02.01.03.0020.000533%
Fatigue08.01.01.0020.001598%
Headache17.14.01.0010.000533%
Influenza22.07.02.001; 11.05.03.0010.000533%Not Available
Muscle spasms15.05.03.0040.001865%
Nausea07.01.07.001--
Pain08.01.08.0040.000533%
Pneumonia22.07.01.003; 11.01.09.0030.000799%Not Available
Seizure17.12.03.0010.000533%
Vomiting07.01.07.0030.000799%
Weight decreased13.15.01.0050.000533%
Malignant neoplasm progression16.16.01.0050.000208%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.000533%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.001066%
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